A. Planning and conducting MRC-funded research
A.1 Those planning and delivering MRC-funded research should have the necessary expertise, professional skills and experience to deliver the project proposed. This may include seeking specialist advice or securing access to expertise through collaboration. Plans should include an assessment of all resources needed (including staff, space, funding, facilities, biological resources and clinical support) to ensure the study is viable within the available means and the efficient and proper use of all resources. This position should be reviewed as the project progresses. Researchers supported by the MRC should consider at an early stage of the design of the project how they will adhere to the principles and standards of Good Research Practice over the course of their research and aim to anticipate any issues or challenges that might arise.
A.2 The rationale for the study and any subsequent modifications must be clearly documented within a well maintained system, for example in project proposals, contracts, protocol documents, laboratory notebooks or as electronic records. All projects must be documented clearly, systematically and in a timely manner, including clear outcomes and end points, plans for statistical analysis, any ethical and regulatory approvals and any subsequent amendments. Key records or documents should be held in an accessible form. Any changes should be validated and recorded with appropriate version control by the researcher responsible, to establish the provenance of the study and protect intellectual property.
A.3 MRC-funded research must adhere to current ethical standards, safety practices, relevant legal requirements, local organisational policies and other guidelines. Researchers should ensure they are aware of, and keep up to date with, all the regulatory, ethical and governance requirements that may apply to their area of research and are working with the teams and individuals within their organisations who have a corporate responsibility to ensure that these requirements are adhered to within the organisations. All appropriate licences and permissions must be in place before the research starts and updated as necessary if plans change. The expectations and requirements of professional codes of conduct and standards, including arrangements for managing consent and information governance should be addressed in the planning and conduct of the study (see section D below).
A.4 For all research involving people as participants, their tissues or data, the relevant principles of Good Clinical Practice (GCP), an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects, should be followed. Where practicable, consent that is freely given and informed should be sought from all competent participants. Guidance on writing participant information is available from the National Research Ethics Service (NRES); this includes guidance for research that involves adults who lack capacity to give consent or children.
Consent discussions should include how feedback on any health related finding will be handled, what withdrawal from a study will mean in practice and that this can occur at any time and for any reason up to the point of data analysis or up to the point of submission for publication. In line with the MRC’s policy on data and tissue sharing, participants should also be made aware of potential reuse in future research and the arrangements for consent.
A.6 Responsibilities for overseeing the scientific and ethical conduct of the study must be identified, allocated and agreed as the scientific plans are put into practice. This is especially important in projects involving patients, volunteers or confidential or identifiable data, tissue, biological samples and animals and in other complex, collaborative programmes.
A.7 Research organisations should have appropriate research governance systems, in which roles are allocated to meet corporate and individual project responsibilities, and are accepted and carried out within a sound research and project management framework. This may involve the identification of sponsors, appropriate and proportionate quality, risk management and monitoring systems, or the use of preferred project management processes or tools. When considering proportionate risks important aspects to consider include the impact on research delivery, supporting creativity, the credibility and robustness of results and the risks involved in methods used in studies involving human participants.
A.8 The proper use and maintenance of equipment and systems is an important element of the research process. Appropriate procedures should be in place and responsibilities assigned to ensure training and support for use, regular servicing and calibration of equipment by trained staff, appropriate records of calibration, servicing, faults, breakdowns and misuse.
A.9 Where possible, and most often for studies involving patients and volunteers, researchers should engage with service-users, carers, representative groups and other stakeholders and beneficiaries in the design, conduct, analysis and reporting of research. Advisory bodies which promote active public and patient involvement should be consulted as appropriate:
